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Details for New Drug Application (NDA): 020883
» See Plans and Pricing
NDA 020883 describes ARGATROBAN, which is a drug marketed by Amneal Pharms Co, Fresenius Kabi Usa, Hikma Pharm Co Ltd, Hospira Inc, Mylan Institutional, Novartis, Par Sterile Products, Teva Pharms Usa, Sandoz, Eagle Pharms, Gland Pharma Ltd, and Aurobindo Pharma Ltd, and is included in thirteen NDAs. It is available from eight suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the ARGATROBAN profile page.
The generic ingredient in ARGATROBAN is argatroban. There are eleven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the argatroban profile page.
The generic ingredient in ARGATROBAN is argatroban. There are eleven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the argatroban profile page.
Summary for 020883
| Tradename: | ARGATROBAN |
| Applicant: | Novartis |
| Ingredient: | argatroban |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 020883
| Mechanism of Action | Thrombin Inhibitors |
Suppliers and Packaging for NDA: 020883
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ARGATROBAN | argatroban | INJECTABLE;INJECTION | 020883 | NDA | Novartis Pharmaceuticals Corporation | 0078-0930 | 0078-0930-61 | 1 VIAL in 1 CARTON (0078-0930-61) > 2.5 mL in 1 VIAL |
Paragraph IV (Patent) Challenges for 020883
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ARGATROBAN | INJECTABLE;INJECTION | argatroban | 020883 | 2007-09-24 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 250MG/2.5ML (100MG/ML) | ||||
| Approval Date: | Jun 30, 2000 | TE: | AP | RLD: | Yes | ||||
Expired US Patents for NDA 020883
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | ARGATROBAN | argatroban | INJECTABLE;INJECTION | 020883-001 | Jun 30, 2000 | Start Trial | Start Trial |
| Novartis | ARGATROBAN | argatroban | INJECTABLE;INJECTION | 020883-001 | Jun 30, 2000 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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